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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Automated Platelet Aggregation
510(k) Number K103555
Device Name MULTIPLATE 5.0 AGGREGOMETER
Applicant
Verum Diagnostica GmbH
Reichenbachstrasse 27
Munich,  DE 80469
Applicant Contact MAXIMILIAN ZUCKER
Correspondent
Verum Diagnostica GmbH
Reichenbachstrasse 27
Munich,  DE 80469
Correspondent Contact MAXIMILIAN ZUCKER
Regulation Number864.5700
Classification Product Code
JOZ  
Date Received12/03/2010
Decision Date 07/27/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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